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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 10 FDA device recalls.

Clear
DateProductReasonClassFirm
Jan 14, 2022 CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex Optic nerve head angiography scan to be turned off due to its distribution without pre-market cle... Class II Carl Zeiss Meditec, Inc.
Jul 8, 2021 Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRU... Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope ... Class II Carl Zeiss Meditec, Inc.
Dec 6, 2018 VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE)... VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may ex... Class II Carl Zeiss Meditec, Inc.
Oct 16, 2018 The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX E... Under certain fault conditions, the existing design may expose the operator to a hazardous voltag... Class II Carl Zeiss Meditec, Inc.
Oct 23, 2013 Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, ... The user database delivered for download contained an erroneous value. Specifically the "aO" cons... Class II Carl Zeiss Meditec, Inc.
Oct 23, 2013 Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, ... The user database delivered for download contained an erroneous value. Specifically the "aO" cons... Class II Carl Zeiss Meditec, Inc.
Apr 18, 2013 Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI ... Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical micros... Class II Carl Zeiss Meditec, Inc.
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, Inc.
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, Inc.
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.